Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337942
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-15
Brief Title:
Deceased Donor Bladder or Combined Kidney-bladder Transplantation a Phase 0 First-in-human Study
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Vascularized Composite Bladder Allograft Transplantation a Phase 0 First-in-human Study for Deceased Donor Bladder or Combined Kidney-bladder Transplantation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to demonstrate the feasibility of bladder transplantation in patients with terminal bladder diseases who would benefit from a new bladder or a combined kidney and bladder transplant The main questions it aims to answer are
Is human bladder transplantation feasible and safe
How will the new bladder function in terms of storage and emptying
Participants will undergo a bladder-only or combined kidney and bladder transplantation They will then be followed for two years to evaluate the efficacy safety and functionality of the bladder transplant
Is human bladder transplantation feasible and safe
How will the new bladder function in terms of storage and emptying
Participants will undergo a bladder-only or combined kidney and bladder transplantation They will then be followed for two years to evaluate the efficacy safety and functionality of the bladder transplant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None